Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT01153620
Status:
COMPLETED
Last Update Posted:
2012-04-06
First Post:
2010-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077331', 'term': "Ringer's Solution"}], 'ancestors': [{'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+41 58 258 55 47', 'title': 'Medical Affairs Manager', 'organization': 'B. Braun Medical, Centre of Excellence'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': "Ringer's Solution", 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lavasept 0.04%', 'otherNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reduction (log10) in Colony Forming Units', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'units': 'wounds', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lavasept 0.04%', 'description': 'Reduction in log 10 Colony Forming Units after 60 minutes of treatment'}, {'id': 'OG001', 'title': "Ringer's Solution", 'description': 'Reduction in log 10 Colony Forming Units after 60 minutes of treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0.734', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.006', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '60 minutes', 'description': 'Comparison of the log10 reduction in CFU after 60 minutes of treatment application.', 'unitOfMeasure': 'log 10 Colony Forming Units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'wounds', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population: comprising all wounds having received the study treatment for any duration (n=61).'}, {'type': 'SECONDARY', 'title': 'Local Tolerability: Pruritis Burning', 'timeFrame': '60 minutes', 'description': 'Local tolerability after 60 minutes of treatment application.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Reduction in CFU', 'timeFrame': '15 minutes, 30 minutes and 60 minutes', 'description': 'Comparison of the percentage reduction in CFU after 15, 30 and 60 minutes of treatment application', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Comparison of the Percentage of Patients With Target Wounds <50 CFU', 'timeFrame': '60 minutes', 'description': 'Comparison of the percentage of patients with target wounds \\<50 CFU after 60 minutes of treatment application', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': "Ringer's Solution"}, {'id': 'FG001', 'title': 'Lavasept 0.04%'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'comment': '30 patients (31 wounds)', 'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'comment': '30 patients (31 wounds)', 'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Location: Emergency roon in University Hospital'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': "Ringer's Solution"}, {'id': 'BG001', 'title': 'Lavasept 0.04%'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.63', 'spread': '24.487', 'groupId': 'BG000'}, {'value': '47.68', 'spread': '23.019', 'groupId': 'BG001'}, {'value': '47.66', 'spread': '23.553', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Switzerland', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-05', 'studyFirstSubmitDate': '2010-06-29', 'resultsFirstSubmitDate': '2011-10-21', 'studyFirstSubmitQcDate': '2010-06-29', 'lastUpdatePostDateStruct': {'date': '2012-04-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-10-21', 'studyFirstPostDateStruct': {'date': '2010-06-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction (log10) in Colony Forming Units', 'timeFrame': '60 minutes', 'description': 'Comparison of the log10 reduction in CFU after 60 minutes of treatment application.'}], 'secondaryOutcomes': [{'measure': 'Local Tolerability: Pruritis Burning', 'timeFrame': '60 minutes', 'description': 'Local tolerability after 60 minutes of treatment application.'}, {'measure': 'Reduction in CFU', 'timeFrame': '15 minutes, 30 minutes and 60 minutes', 'description': 'Comparison of the percentage reduction in CFU after 15, 30 and 60 minutes of treatment application'}, {'measure': 'Comparison of the Percentage of Patients With Target Wounds <50 CFU', 'timeFrame': '60 minutes', 'description': 'Comparison of the percentage of patients with target wounds \\<50 CFU after 60 minutes of treatment application'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute traumatic wounds'], 'conditions': ['Wounds']}, 'descriptionModule': {'briefSummary': "The primary objective of the study is to assess the antiseptic efficacy of Lavasept 0.04% when used as an antiseptic agent and to compare these with Ringers' solution in patients with acute traumatic wounds."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with acute traumatic cut, crush, abrasion, bite or stab wounds Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations\n* Wounds that are a minimum of approximately 4 cm2 in size\n* Ability to read and understand the German patient information sheet and informed consent form\n\nExclusion Criteria:\n\n* \\< 18 years of age\n* Pregnancy\n* Immunosuppression\n* Wounds caused by a burn\n* Wounds that require treatment of hyaline cartilage, the central nervous system, peritoneum, meningae, inner / middle ear or inner eye\n* Simultaneous participation in another clinical trial\n* Wounds that require immediate surgical or medical treatment as well patients who are critically ill\n* Patient with a known allergy to the active agent or any of the excipients\n* Wounds that are \\>3 cm in depth\n* Wounds that have not received medical treatment for ≥6 hours\n* Heavily bleeding wounds\n* Open fractures, joints or tendons\n* Wounds of the face'}, 'identificationModule': {'nctId': 'NCT01153620', 'acronym': 'Lavasept 2', 'briefTitle': 'The Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds', 'organization': {'class': 'INDUSTRY', 'fullName': 'B. Braun Ltd. Centre of Excellence Infection Control'}, 'officialTitle': 'Randomized, Double-blind, Controlled Clinical Trial on the Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds', 'orgStudyIdInfo': {'id': 'OPM-CIC-G-H-0901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': "Ringer's Solution", 'interventionNames': ["Other: Ringer's Solution"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lavasept 0.04%', 'interventionNames': ['Drug: Lavasept 0.04%']}], 'interventions': [{'name': 'Lavasept 0.04%', 'type': 'DRUG', 'description': "Method of Administration A sterile compress will be saturated with Lavasept® 0.04% / Ringers' solution and placed on the wound.\n\nDosage Lavasept® 0.04% 50 ml 50ml or as much needed to completely saturate the compress.\n\nTreatment Duration 60 minutes", 'armGroupLabels': ['Lavasept 0.04%']}, {'name': "Ringer's Solution", 'type': 'OTHER', 'description': "Method of Administration A sterile compress will be saturated with Lavasept® 0.04% / Ringers' solution and placed on the wound.\n\nDosage Ringers' solution 50ml or as much needed to completely saturate the compress. Treatment Duration 60 minutes", 'armGroupLabels': ["Ringer's Solution"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital of Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Hans Peter Simmen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B. Braun Ltd. Centre of Excellence Infection Control', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}